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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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This study will examine the tolerability and toxicity of topically applied Nepafenac 0.3% vs ketorolac 0.5% among patients undergoing cataract surgery.
This will be a randomized, prospective, controlled, open-label study, comparing the tolerability and toxicity of two commercially available non-steroidal anti-inflammatory eye drops, nepafenac 0.3% and ketorolac 0.5% (generic formulation). The study will involve one eye of each subject. The study will follow good clinical practices (GCP). The primary outcome measure will be tolerability of the study medication as measured by the eye drop comfort survey instrument.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nepafenac 0.3% | Active Comparator | Patients in this arm will receive nepafenac 0.3% eye drops once daily following cataract surgery, combined with a topical antibiotic and steroid. This regimen is FDA approved and withing the standard of care. |
|
| ketorolac 0.5% | Active Comparator | Patients in this arm will receive ketorolac 0.5% eye drops four times daily following cataract surgery, combined with a topical antibiotic and steroid. This regimen is FDA approved and withing the standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nepafenac 0.3% | Drug | Patients in this group will receive nepafenac 0.3% eye drops once daily after cataract surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of nepafenac vs ketorolac | Patients will fill out a survey describing eye drop tolerability at 14-28 days | 14-28 days |
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Inclusion Criteria:
Exclusion Criteria
Active, systemic or local disease condition that causes clinically significant ocular surface irritation such that it could interfere with the questions in the survey and examination findings.
Any of the following ocular (eye or eyelid) conditions in either eye within 1 Months prior to the enrollment visit:
Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis
Severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis)
Eyelid abnormalities that significantly affect lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis)
Ocular surface abnormality that may compromise corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, or map dot fingerprint dystrophy)
Participation in another ophthalmic clinical trial involving a therapeutic drug or device within 30 days prior to the distribution of the survey
Participation in this trial in the same patient's fellow eye.
Patients who are pregnant or breastfeeding or who may become pregnant during participation in the study.
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| Name | Affiliation | Role |
|---|---|---|
| John A Hovanesian, MD | UCLA Jules Stein Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harvard Eye Associates | Laguna Hills | California | 92653 | United States | ||
| Cincinnati Eye Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16196117 | Result | Jabs DA, Nussenblatt RB, Rosenbaum JT; Standardization of Uveitis Nomenclature (SUN) Working Group. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. Am J Ophthalmol. 2005 Sep;140(3):509-16. doi: 10.1016/j.ajo.2005.03.057. | |
| 14508260 | Result | Bron AJ, Evans VE, Smith JA. Grading of corneal and conjunctival staining in the context of other dry eye tests. Cornea. 2003 Oct;22(7):640-50. doi: 10.1097/00003226-200310000-00008. |
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There is not a plan to make individual patient data available.
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C414203 | nepafenac |
| D020910 | Ketorolac |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| ketorolac | Drug | Patients in this group will receive ketorolac 0.5% eye drops four times daily after cataract surgery. |
|
| Edgewood |
| Kentucky |
| 41017 |
| United States |
| D006571 | Heterocyclic Compounds |